- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01796821
Efficacy and Safety Profiles of SR-T100 Gel on External Genital Warts/Condyloma Acuminate(EGWs)
A Double-Blind, Vehicle Controlled, Randomized, Phase II Study of SR-T100 Gel on External Genital Warts/Condyloma Acuminate (EGWs)
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Kaohsiung, Taiwan
- Kaohsiung Medical University Chung-Ho Memorial Hospital
-
Kaohsiung, Taiwan
- Kaohsiung Municipal Ta-Tung Hospital
-
Tainan, Taiwan
- National Cheng Kung University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female; aged ≥ 20 years old.
- Patients who accept to enter the study by signing written informed consent.
- Each patient has 1 to 10 clinically diagnosed EGW(s). If patient has only 1 genital wart, the diameter of the genital wart must be no less than 5 mm.
- Female patients have lesion(s) on labia majora, labia minora, clitoris and/or groin.
- Male patients have lesion(s) on glans, shaft and/or foreskin.
- Each patient has at least 1 histologically proved EGW.
- Patients agree to apply the study medication on "clinical diagnosed lesion(s)" with occlusive dressing(s) once daily for at least 20 hours per day and "clinical normal skin on the treated area" thrice daily without occlusive dressing.
- Patients allow diagrammed mapping and photography on genital warts. And patients agree to be used of these data as part of the study data package.
- Patients in good general health condition (performance status ≤ 2 Eastern Cooperative Oncology Group (ECOG)).
- Female patients with child-bearing potential must take reliable contraception method(s) during the participation of the study.
- Patients must agree to use effective boundary barrier for birth control and re-infection of EGW
Exclusion Criteria:
- Patients with peri-anal warts.
- Male patients with warts on scrotum or perineum.
- Patients with other genital infections.
- Patients with internal genital warts (such as urethral, intra-vaginal, cervical, rectal, or intra-anal genital warts).
- Patients with active systemic infections.
- Patients with other genital diseases that may confound evaluation and treatment for genital warts.
- Patients with immuno-compromised medical condition.
- Patients have received investigational drug prior to 30 days of randomization visit.
- Patients with cancer or cancer history within 5 years of the randomization visit.
- Patients have on-going human papilloma virus (HPV) infection other than genital area.
- Patients with human immunodeficiency virus (HIV), venereal disease research laboratory (VDRL), or treponema pallidum particle agglutination assay (TPHA) positive result.
- Female patients have high-grade pathology in Papanicolaou smear tests based on Bethesda system.
- Female patients are pregnant or lactating.
- Patients have history of allergy or sensitivity to Solanum undatum plant extract, SM, or SR-T100 gel excipients including carbomer, propylene glycol, and triethanolamine.
Patients with prohibited pre-medication or procedures shown below:
- Physical modalities, such as laser ablation, electrocautery or cryotherapy, for genital warts treatment on treated area within 4 weeks prior to randomization visit.
- Topical administered medication for genital warts treatment, such as polyphenon E, podophyllotoxin, imiquimod, or 5-fluorouracil (5-FU), within 12 weeks prior to randomization.
- Medications of cytotoxic, immunomodulator (inhaled and topical steroid not on ano-genital areas are not prohibited), systematic antiviral agent in 4 weeks prior to randomization visit.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Vehicle gel
vehicle gel is used as a control group.
The maximum daily dosage is 3 times of 400+/-100 mg of gel, meaning no more than 1,500 mg of gel.
Patients should wash thoroughly their hands, then squeeze until 4 cm of gel is out from the aluminum tube.
Apply gel on the lesion warts and on the clinical normal skin on the treated area.
|
Clinical diagnosed lesion site(s): Topical application once daily with occlusive dressing. Clinical normal skin on treated area: Topical application thrice daily without occlusive dressing. Total application <1,500 mg gel per day. |
Active Comparator: SR-T100 gel with 1.0 % SM
SR-T100 contains 1.0% SM.
The maximum daily dosage is 3 times of 400+/-100 mg of gel, meaning no more than 1,500 mg of gel.
Patients should wash thoroughly their hands, then squeeze until 4 cm of gel is out from the aluminum tube.
Apply gel on the lesion warts and on the clinical normal skin on the treated area.
|
Clinical diagnosed lesion site(s): Topical application once daily with occlusive dressing. Clinical normal skin on treated area: Topical application thrice daily without occlusive dressing. Total application <1,500 mg gel per day. |
Active Comparator: SR-T100 gel with 2.3% SM
SR-T100 contains 2.3% SM.
The maximum daily dosage is 3 times of 400+/-100 mg of gel, meaning no more than 1,500 mg of gel.
Patients should wash thoroughly their hands, then squeeze until 4 cm of gel is out from the aluminum tube.
Apply gel on the lesion warts and on the clinical normal skin on the treated area.
|
Clinical diagnosed lesion site(s): Topical application once daily with occlusive dressing. Clinical normal skin on treated area: Topical application thrice daily without occlusive dressing. Total application <1,500 mg gel per day. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Total clearance rate of baseline lesion(s)
Time Frame: 16 weeks
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total clearance rate of all lesion(s)
Time Frame: 16 weeks
|
16 weeks
|
|
Period duration of achieving total clearance of baseline lesion(s) and new lesion(s)
Time Frame: 16 weeks
|
16 weeks
|
|
Partial clearance rate
Time Frame: 16 weeks
|
16 weeks
|
|
New lesion(s) occurrence rate
Time Frame: 16 weeks
|
16 weeks
|
|
Recurrence rate in the 12-week follow-up time
Time Frame: 28 weeks
|
28 weeks
|
|
Recurrence time period
Time Frame: 28 weeks
|
28 weeks
|
|
Safety: evaluate the changes occurring from baseline to EOT visit
Time Frame: 28 weeks
|
including PE, vital sign, lab.
test, local skin reaction, and adverse event, etc.
|
28 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Cheng-Yang Chou, M.D., National Cheng Kung University, Tainan, Taiwan
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GESRTGWA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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